Autologous Stem Cell Transplantation, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Stem Cell Mobilization
Conditions
Keywords
non-Hodgkin's lymphoma, Hodgkin's lymphoma, stem cell mobilization, autologous stem cell transplantation
Brief summary
The aim of this study is to evaluate Plerixafor (MOZOBIL) plus recombinant human G-CSF (G-CSF) efficiency in mobilizing sufficient number of stem cells from Lymphoma (NHL and HL) patients for autologous transplantation.
Interventions
DRUGPlerixafor
Plerixafor (mozobil) 240 mcg/kg SC will be administered in the evening, 10 hours prior to initiation of apheresis.G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
Sponsors
Sheba Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients eligible and planned for an autologous haematopoietic stem cell transplantation. 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 1.2 WBC count ≥2.5x109/L. 1.3 Absolute neutrophil count ≥1.5x109/L. 1.4 Platelet count ≥100x109/L 1.5 Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation. 1.6 Previously, heavily pretreated lymphoma patients or patients suspected to have a poor bone marrow stem cell reserve for at least one of the following: * \>2 lines of chemotherapy. * Previous radiotherapy involving bone marrow * Prior therapy with specific stem cell toxic chemotherapeutic agents * Platelets count pre-mobilisation, ≤150.103 x mm3 * Level of circulating CD34+ ≤ 20 cells/mcL prior to apheresis on the collection day * Patients \> 60 years of age
Exclusion criteria
2.1 Lymphoma patients that did not fulfil the inclusion criteria. 2.2 History of any acute or chronic leukemia (including myelodysplastic syndrome. 2.3 Prior allogeneic or autologous transplantation. 2.4 Inability to tolerate stem cell harvest. 2.5 Peripheral venous access not possible. 2.6 Pregnant or nursing women. 2.7 Positive serology for hepatitis B or C. 2.8 Acute infection (febrile, i.e. temperature \> 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF. 2.9 HIV positive. 2.10 Left ventricular ejection fraction \< 50%. 2.11 DLCO \< 50%. 2.12 Splenectomised or splenic irradiation. 2.13 Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study. 2.14 Treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mobilisation success rate | 4 weeks | Mobilisation success rate is defined as the mobilisation of a PBSC graft containing \>2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach \>2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching \>5x10 CD34+ cells/kg in ≤ 4 apheresis sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| engraftment after transplantation | 100 days | speed of engraftment is determined by the time until recovery of blood counts after transplantation. |
Countries
Israel
Outcome results
None listed